cGMP Regulations definition

cGMP Regulations means the applicable current Good Manufacturing Practices as promulgated by the FDA from time to time under the Act, as presently codified in 21 CFR Parts 210 and 211.
Sample 1Sample 2
cGMP Regulations means the applicable current Good Manufacturing Practices as promulgated under ICH Q7A-Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, U.S. Federal Food, Drug and Cosmetic Act at 21 CFR and the EEC Guide to Good Manufacturing Practices for Medical Products (Vol. IV — rules governing medical products in the European Community 1989) in the most recent version.
Sample 1Sample 2Sample 3
cGMP Regulations means the regulations defining and regulating current Good Manufacturing Practices (GMP) as contained from time to time in the Act and related regulations, or any successor laws or regulations governing the manufacture, handling, storage and control of the Product, including without limitations, regulations promulgated by the FDA under 21 C.F.R. §§ 210, 211, EC Directive 2003/94/EC, and the World Health Organization (WHO) “Guide to good manufacturing practice (GMP) requirements, and the International Conference on Harmonization (ICH), Guidance for Industry Q7A GMP Guidance for APIs.
Sample 1

Examples of cGMP Regulations in a sentence

  • Hollister-Stier is responsible for formalxx xxxxxxxxxxxxg and documexxxxx xxx xxxxxres to follow or deviations from the Master Manufacturing Batch Production and Control Records or QC analytical testing methods or procedures, any test or in-process test which fails to meet Specifications and any failures of the equipment, utilities, facility or other systems used to manufacture the Intermediate and Product, in accordance with Hollister-Stier's procedures and cGMP Regulations.

  • Economic Analysis of New FDA Food cGMP Regulations and Related Legislative Initiatives – Subtask 2: Expert Opinions on Current Food Manufacturing Practices – June 30, 2010 (Ref.

  • In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP Regulations, the provisions of the Quality Agreement shall govern.

  • Genzyme shall have the right to audit once annually each of those portions of the manufacturing, finish processing or storage facilities where Aldurazyme is being manufactured, finished or stored, or any subcontractor who is manufacturing, finishing or storing Aldurazyme for BioMarin, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with the cGMP Regulations, as the same may be amended from time to time.

  • BioMarin shall have the right to audit once annually each of those portions of the distribution or storage facilities of Genzyme or its Affiliates where Aldurazyme is being stored, sold or distributed, or any subcontractor or other Third Party who is storing, selling or distributing Aldurazyme for Genzyme, at any time during regular business hours and upon reasonable advance notice to ascertain compliance with cGMP Regulations, as the same may be amended from time to time.

  • Upon reasonable advance written notice to Unigene, Novartis, shall have the right to audit the manufacturing and warehousing operations of Unigene to assure that the operations are done in accordance with cGMP Regulations, subject to confidentiality requirements/agreements.

  • Hollister-Stier is responsible for formally investigating and xxxumenting any failures to follow or deviations from Manufacturing Procedures or analytical testing procedures, any test or in-process test which fails to meet Specifications or any failure of the equipment, utilities, facility or other systems used to manufacture the Intermediate(s) and Product(s), in accordance with Hollister-Stier's procedures and cGMP Regulations.

  • If the new application is from a new manufacturing site, FDA will conduct inspection of the facility or use other means to verify whether the facility complies with cGMP Regulations and/or guideline before a product is registered.

  • Applicable Law shall mean all applicable laws, rules, and regulations and shall include cGMP Regulations.

  • Economic Analysis of New FDA Food cGMP Regulations and Related Legislative Initiatives – Subtask 3: Expert Opinions on Current Food Manufacturing Practices of Distributors/Consolidators/Wholesalers and Packers of Produce and Processed Foods – September 17, 2010 (Ref.


More Definitions of cGMP Regulations

cGMP Regulations means the current good manufacturing practices (“CGMP”) promulgated by the FDA, as amended, including those currently set out in Parts 210 and 211 of Title 21 of the Code of Federal Regulations.
Sample 1
cGMP Regulations means the regulatory requirements for current good manufacturing practices with respect to the Processing, storage and Release Testing of Bulk Product under this Agreement, including (as applicable): the United States current Good Manufacturing Practices pursuant to the FDCA and pursuant to the relevant regulations found in Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 210, 211, 610 and 611), the European Union’s current Good Manufacturing Practices pursuant to EC Directive 2003/94/EC of 8 October 2003, and the International Conference on Harmonisation Guidance for Industry, as applicable, including Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, in the case of Q7 as applicable to the activities carried out by CoreRx under this Agreement, and any comparable regulatory requirements designated by the Parties in a Purchase Order, as such regulatory requirements may be amended from time to time.
Sample 1
cGMP Regulations means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices, including but not limited to EU Directives 2003/94/EC code of GMP and 2001/83/EC as amended by 2004/27/EC code of practice for the QP, and all other relevant EU and UK principles and guidelines, ICH Tripartite Guidance Q7A and guidance documents relating to GMP and GDP as well as applicable US Current Good Manufacturing Practices (21 CFR 210 and 211) that govern the standards of manufacture for any product intended for human use, as appropriate.
Sample 1

Related to cGMP Regulations

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164.

  • ISA Regulations means The Individual Savings Account Regulations 1998, as amended or replaced from time to time.

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • CDM Regulations means the Construction (Design and Management) Regulations 2015;

  • UCITS Regulations means the European Communities (Undertakings for Collective

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • Privacy Regulations means the Privacy and Electronic Communications (EC Directive) Regulations 2003 as amended in 2004, 2011, 2015 and 2016 and as may be further amended from time to time;

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • OFAC Regulations means the regulations promulgated by OFAC, as amended from time to time.

  • SEBI ICDR Regulations means Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended;

  • CIP Regulations has the meaning provided in Section 9.07.

  • the 1997 Regulations means the Zebra, Pelican and Puffin Pedestrian Crossing Regulations 1997.

  • TRADES Regulations means the regulations of the United States Department of the Treasury, published at 31 C.F.R. Part 357, as amended from time to time. Unless otherwise defined herein, all terms defined in the TRADES Regulations are used herein as therein defined.

  • WHFIT Regulations Treasury Regulations section 1.671-5, as amended.

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • Radio Regulations means the Radio Regulations annexed to, or regarded as being annexed to, the most recent International Telecommunication Convention which may be in force at any time.

  • the 2002 Regulations means the Traffic Signs Regulations and General Directions 2002;

  • SBE Regulations means the written regulations and procedures adopted pursuant to this chapter for procurement of Supplies, Services and Public Works.

  • FHA Regulations Regulations promulgated by HUD under the National Housing Act, codified in 24 Code of Federal Regulations, and other HUD issuances relating to FHA Loans, including the related handbooks, circulars, notices and mortgagee letters.

  • Data Protection Regulation means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 20161 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation);

  • EEA Regulations means the Immigration (European Economic Area) Regulations 2006.

  • the 2001 Regulations means the Water Supply (Water Quality) Regulations 2001[63];